Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT01449305
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2011-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mingrong@bioisred.com', 'phone': '886-8-7628188', 'title': 'Mirror Hsieh', 'organization': 'isRed Pharma & Biotech Research Corporation'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 months', 'eventGroups': [{'id': 'EG000', 'title': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles.'}], 'classes': [{'title': 'First menstrual cycle', 'categories': [{'measurements': [{'value': '-0.810', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Second menstrual cycle', 'categories': [{'measurements': [{'value': '-1.29', 'spread': '1.81', 'groupId': 'OG000'}]}]}, {'title': 'Third menstrual cycle', 'categories': [{'measurements': [{'value': '-1.74', 'spread': '2.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle', 'description': 'The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).', 'unitOfMeasure': 'scores', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects were asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles in house. Primary objective was analyzed based on the Per-protocol (PP) population.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Medicine Administration for Pain Relief During Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles.'}], 'classes': [{'title': 'First menstrual cycle', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Second menstrual cycle', 'categories': [{'measurements': [{'value': '9.52', 'groupId': 'OG000'}]}]}, {'title': 'Third menstrual cycle', 'categories': [{'measurements': [{'value': '7.14', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'first menstrual cycle, second menstrual cycle and third menstrual cycle', 'description': 'Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'It was analyzed based on the PP population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Forty-four (44) subjects enrolled into the study. Forty-two (42) subjects completed the study from 2011-10-11 to 2012-06-23 at the PingTung Christian Hospital (60, Dallan Road, Pingtung, Taiwan).', 'preAssignmentDetails': 'This is an Open-label study design. The subject must be qualified for the study by fulfilling all of the inclusion and none of the exclusion criteria. Laboratory values which are out of reference range will not qualify unless the physician deems the deviation not clinically significant (NCS).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '22.4', 'spread': '4.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-01', 'studyFirstSubmitDate': '2011-10-06', 'resultsFirstSubmitDate': '2012-12-28', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2013-02-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-12-28', 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Medicine Administration for Pain Relief During Study Period', 'timeFrame': 'first menstrual cycle, second menstrual cycle and third menstrual cycle', 'description': 'Continue taking pharmacological pain relief if required for subjects was allowed during study period, and it had been recorded.'}], 'primaryOutcomes': [{'measure': 'The Mean Change in Maximum Pain Level at Each Menstrual Cycle From Baseline', 'timeFrame': 'baseline, first menstrual cycle, second menstrual cycle and third menstrual cycle', 'description': 'The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain).'}]}, 'conditionsModule': {'conditions': ['Dysmenorrhea']}, 'descriptionModule': {'briefSummary': 'To evaluate the mean change in menstrual pain intensity during menstrual cycles from baseline after wearing Nanoone Woman Underwear in women with primary dysmenorrhea', 'detailedDescription': 'The severity of dysmenorrhea pain experienced by subjects will be evaluated on a VAS, ranging from zero (no pain) to ten (very severe pain). Subjects will be asked to use the VAS scoring system to record, on a provided sheet, their experienced menstrual pain level daily during menstrual bleeding for a total of three consecutive menstrual cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females aged below 40 years old.\n2. Screened by inquiry and diagnosed as primary dysmenorrhea by gynaecologist with pelvic ultrasonography.\n3. Female subject who is:\n\n * using adequate contraception since last menstruation and no plan for conception during the study.\n * non-lactating.\n * has negative pregnancy test (urine) within 14 days prior to the study.\n4. Informed consent form signed.\n\nExclusion Criteria:\n\n1. Sensitivity to study product.\n2. Patient has been diagnosed with secondary dysmenorrhea (defined as identifiable pelvic pathology).\n3. Patient has clinically significant physical disability or abnormal findings on physical examination or laboratory testing judged by the investigator or co-investigator.\n4. Participation of any clinical investigation during the last 30 days.'}, 'identificationModule': {'nctId': 'NCT01449305', 'briefTitle': 'Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chen Yi Enterprise, Co., Ltd.'}, 'officialTitle': 'Research on Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea', 'orgStudyIdInfo': {'id': 'Nanoone'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nanoone Woman Underwear', 'description': '"Nanoone" negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body.', 'interventionNames': ['Device: Nanoone Woman Underwear']}], 'interventions': [{'name': 'Nanoone Woman Underwear', 'type': 'DEVICE', 'description': 'Chen Yi Enterprise, Co., Ltd. design a kind of negative ion materials can supply delocalized electron, and add fiber inside, make clothes to wear in the body, no external power or battery, only depend on infrared body photon hit of thermoelectric effect or heart compression pulse, blood flow of piezoelectric, therefore can sustained sufficient amount of effective negative ion, to eliminate positive ions in vivo, or make oxygen free radical to obtain the lack electrons. Decrease active free radical and get non toxic effect in short time.', 'armGroupLabels': ['Nanoone Woman Underwear']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pingtung City', 'country': 'Taiwan', 'facility': 'PingTung Christian Hospital', 'geoPoint': {'lat': 22.67135, 'lon': 120.48814}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chen Yi Enterprise, Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}